Longer trial duration is usually more favorable. W
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Posted On: 01/31/2022 9:03:32 AM
Longer trial duration is usually more favorable. Where you could see a reduction in p value is when the body develops a tolerance for the drug. In the case of leronlimab the reduction of inflammatory cytokines would actually lower CCR5 expression further so there's no development of tolerance.
Bigger trial sizes will improve p values if the drug is having effect. With the fat reducing drugs it does take time to eliminate that fat and hopefully stop or reverse fibrosis. No fat reducing drug has been shown to have a significant effect on fibrosis yet.
The phase 3 NASH trials I've looked at have been a year or longer. Ours will probably have the same type of timeline. With leronlimab going after the inflammation as the primary effect and also having fat reduction I would expect much faster results. With a large enough trial size we might get a halt recommendation for efficacy at the interim from the DSMB.
Bigger trial sizes will improve p values if the drug is having effect. With the fat reducing drugs it does take time to eliminate that fat and hopefully stop or reverse fibrosis. No fat reducing drug has been shown to have a significant effect on fibrosis yet.
The phase 3 NASH trials I've looked at have been a year or longer. Ours will probably have the same type of timeline. With leronlimab going after the inflammation as the primary effect and also having fat reduction I would expect much faster results. With a large enough trial size we might get a halt recommendation for efficacy at the interim from the DSMB.
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